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NCT Number: NCT07115615

Exploring the Efficacy of Accelerated Transcranial Direct Current Stimulation (tDCS) as Adjunct to Pharmacotherapy in the Treatment of Obsessive-compulsive Disorder

This study will evaluate the decision-making ability and therapeutic effects of accelerated Transcranial Direct Current Stimulation (tDCS) as adjunct to pharmacotherapy in obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by EEG and MRI.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, China

About this study

The purpose of this study is to examine the decision-making ability and clinical efficacy of accelerated tDCS over orbitofrontal cortex (OFC) as adjunct to pharmacotherapy in treatment of OCD patients.60 OCD patients on stable medication will be randomized into two groups (i.e. active or sham stimulation). Accelerated tDCS stimulation will be performed four times a day, five times a week, for one week. Iowa Gambling Task will be conducted at the baseline, after the one week tDCS and at the 1-month follow-up to evaluate the decision-making ability of OCD patients.The investigators will assess symptom severity before and after one week of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale(Y-BOCS), Clinical Global Impression(CGI), the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory-II (BDI-II), the Beck Anxiety Inventory (BAI), Childhood Trauma Questionnair(CTQ), side-effect questionnaire and other scales will be obtained by a trained investigator.The patients will also receive magnetic resonance imaging (MRI) scan, electroencephalography (EEG).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-60 years old, Han ethnicity, right-handed
  • DSM-5 criteria for OCD;
  • Y-BOCS total score ≥16, receiving stable medication for at least 4 weeks before tDCS stimulation.
  • Years of education ≥9.

Exclusion criteria

  • Any axis I psychiatric disorder comorbidity
  • Severe obsessive-compulsive symptoms that render the patient unable to complete required assessment procedures.
  • Previous treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial direct current stimulation (tDCS).
  • Severe somatic diseases or any physical conditions that may induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, etc.
  • History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or traumatic brain injury/brain surgery.
  • Implantation of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or other internal medical devices.
  • Women who are pregnant or planning to become pregnant in the near future.
  • Serious suicide risks.

Treatment and study plan

high-definition transcranial direct current stimulation

Device

The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode electrode will be localized in front of the right OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8)

Sham tDCS

Device

To demonstrate the same stimulation sensation as under real conditions, only 40 seconds of real stimulation (2mA) are given at the beginning of the treatment. In the remaining 20 minutes, only about 15ms of short current pulses of 110uA occur every 550ms.

Primary outcomes

  1. Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale(Y-BOCS)

    Time frame: Up to 5 weeks

    The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.

Secondary outcomes

  1. The Beck Depression Inventory-II(BDI-II)

    Time frame: Up to 5 weeks

    It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression.

  2. The Beck Anxiety Inventory (BAI)

    Time frame: Up to 5 weeks

    It is a 21-item self-report inventory that is used for measuring the severity of anxiety.

  3. Side-effect questionnaire

    Time frame: Up to 5 weeks

    It consists of ten commonly-reported side effects as well as an "other" category that allows participants to describe experiences/sensations not otherwise covered to rate the intensity of side effects.

Study contacts

Contact information is provided by the study sponsor or research team.

Qing Wang, PhD

CONTACT

[email protected]

+86 19821243355

Qing Zhao, PhD,MD

CONTACT

[email protected]

+86 18516539730

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Exploring the Efficacy of Accelerated Transcranial Direct Current Stimulation (tDCS) as Adjunct to Pharmacotherapy in the Treatment of Obsessive-compulsive Disorder: A Randomized Controlled Trial Using High-resolution MRI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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